Fampyra

fampridine

About

This is a summary of the European public assessment report (EPAR) for Fampyra. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Fampyra.

Treatment with Fampyra should be prescribed and supervised by a doctor experienced in MS. The recommended dose is one tablet taken by mouth, twice a day, 12 hours apart. The tablets should be taken without food.

Patients should be evaluated after two weeks and treatment should be stopped for those who have not shown an improvement. Treatment should also be stopped if a patient’s walking ability worsens or if the patient does not report any benefit.

For the body’s muscles to contract, electrical impulses are transmitted along the nerves to the muscles. In MS, this transmission of electrical impulses is impaired when the protective sheaths around the nerves become damaged, which can lead to muscle weakness, muscle stiffness and difficulty walking.

The active substance in Fampyra, fampridine, is a potassium-channel blocker. It acts on damaged nerves, where it prevents charged potassium particles from leaving the nerve cells. This is believed to have the effect of allowing the electrical impulse to continue travelling along the nerves to stimulate the muscles, making it easier to walk.

The effects of Fampyra were first tested in experimental models before being studied in humans. The company also used data from the scientific literature.

Two main studies were performed comparing Fampyra with placebo (a dummy treatment) in 540 patients with multiple sclerosis. The patients were treated for nine or 14 weeks. The main measure of effectiveness was based on improvements in walking speed along a path of 25 feet (about 7.5 metres). Patients were considered to have responded to treatment if, on at least three out of four occasions, their walking speed was faster than their highest speed before treatment.

Fampyra was effective in improving walking speeds. In one of the main studies, around 35% of patients taking Fampyra responded to treatment compared with 8% of patients taking placebo. In the second study the results were similar with 43% of patients in the Fampyra group responding to treatment compared with 9% in the placebo group.

The side effects seen with Fampyra are mostly neurological (relating to the brain or nerves) and include seizures (fits), insomnia (difficulty sleeping), anxiety, problems with balance, dizziness, paraesthesia (unusual sensations like pins and needles), tremor, headache and asthenia (weakness). The most common side effect reported in clinical studies, affecting around 12% of the patients, is urinary tract infection. For the full list of all side effects reported with Fampyra, see the package leaflet.

Fampyra should not be used in people who may be hypersensitive (allergic) to fampridine or any of the other ingredients. It must not be used with other medicines that contain fampridine or medicines known as ‘inhibitors of organic cation transporter 2’ such as cimetidine. It must not be used in patients who have seizures or have ever had seizures or in patients with kidney problems.

The CHMP considered that Fampyra was likely to benefit approximately one third of patients with MS who have a walking disability, and that patients benefiting from the treatment can be identified at an early stage allowing treatment to be stopped in other patients. The Committee noted that no other medicine was currently approved to treat the symptoms of MS and that the serious side effects with Fampyra were rare. The CHMP therefore concluded that the benefits of Fampyra outweigh its risks for patients with a walking disability and recommended that it be given marketing authorisation.

Fampyra has been given ‘conditional approval’. This means that there is more evidence to come about the medicine, in particular on the medicine’s long-term effects on other aspects of walking ability. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.

The company that makes Fampyra will carry out a long term study on the effectiveness and safety of Fampyra. The study will look at the effects of Fampyra on other aspects of walking ability besides walking speed and will further investigate ways for the earlier identification of patients who respond to Fampyra earlier in order to guide further treatment.

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Conditional Approval

Sometimes, the CHMP recommends that a medicine be given ‘conditional approval’. This happens when the Committee has based its positive opinion on data which, while not yet comprehensive, indicate that the medicine’s benefits outweigh its risks.

The company is given obligations to fulfil, such as the performance of further studies. The approval is renewed on a yearly basis until all obligations have been fulfilled, and is then converted from a conditional approval into a normal approval. Conditional approvals can only be granted for medicines that satisfy an ‘unmet medical need’, meaning the medicine is intended to be used for a disease or condition for which no treatment is readily available, and it is therefore important that patients have early access to the medicine concerned.

Publication details

Publication details for Fampyra

Marketing-authorisation holder

Biogen Idec Ltd

Revision

9

Date of issue of marketing authorisation valid throughout the European Union